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Items: 1 to 20 of 21

1.

Ensuring safe and effective medical devices.

Feigal DW, Gardner SN, McClellan M.

N Engl J Med. 2003 Jan 16;348(3):191-2. No abstract available.

PMID:
12529457
2.

Medical device epidemiology and surveillance: patient safety is the bottom line.

Brown SL, Bright RA, Tavris DR.

Expert Rev Med Devices. 2004 Sep;1(1):1-2. Review. No abstract available.

PMID:
16293003
3.

Medical device regulation: an introduction for the practicing physician.

Maisel WH.

Ann Intern Med. 2004 Feb 17;140(4):296-302. Review.

PMID:
14970153
4.

Left to their own devices: breakdowns in United States medical device premarket review.

Hines JZ, Lurie P, Yu E, Wolfe S.

PLoS Med. 2010 Jul 13;7(7):e1000280. doi: 10.1371/journal.pmed.1000280. Review. No abstract available.

5.

Part II: Sealing holes in the safety net.

Peterson ED, Hirshfeld JW Jr, Ferguson TB, Kramer JM, Califf RM, Kessler LG.

Am Heart J. 2004 Jun;147(6):985-90. Review. No abstract available.

PMID:
15199344
6.

Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

Feldman MD, Petersen AJ, Karliner LS, Tice JA.

J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63. doi: 10.1007/s11606-007-0275-4. Review.

7.

Medical device specificities: opportunities for a dedicated product development methodology.

Santos IC, Gazelle GS, Rocha LA, Tavares JM.

Expert Rev Med Devices. 2012 May;9(3):299-311. doi: 10.1586/erd.12.3. Review.

PMID:
22702261
8.

Ethics considerations for medical device R&D.

Citron P.

Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):307-15. doi: 10.1016/j.pcad.2012.08.004. Review.

PMID:
23217435
9.

Approval of high-risk medical devices in the US: implications for clinical cardiology.

Rome BN, Kramer DB, Kesselheim AS.

Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0. Review.

10.

Assessing the safety of the new 30-night contact lenses.

Schein OD.

Eye Contact Lens. 2003 Jan;29(1 Suppl):S157-9; discussion S166, S192-4. Review. No abstract available.

PMID:
12772756
11.

Review of the processes for FDA oversight of drugs, medical devices, and combination products.

Sweet BV, Schwemm AK, Parsons DM.

J Manag Care Pharm. 2011 Jan-Feb;17(1):40-50. Review. No abstract available.

12.

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective.

Samuels-Reid J, Lawrence B, Millin C, Cope J.

Expert Rev Med Devices. 2012 May;9(3):275-82. doi: 10.1586/erd.12.7. Review.

PMID:
22702258
13.

Critical assessment of new devices.

Hamilton C.

Perfusion. 2007 May;22(3):167-71. Review.

PMID:
18018395
14.

The nurse's role in contributing to new device development.

Weir H, Grocott P, Ram MB.

Nurs Times. 2006 Jun 27-Jul 3;102(26):36-9. Review.

PMID:
16845815
15.

Postmarketing safety of biologics and biological devices.

Woo EJ.

Spine J. 2014 Mar 1;14(3):560-5. doi: 10.1016/j.spinee.2013.09.056. Epub 2013 Dec 14. Review.

PMID:
24342704
16.

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].

Bohnet-Joschko S, Zippel C, Siebert H.

Z Evid Fortbild Qual Gesundhwes. 2015;109(9-10):725-35. doi: 10.1016/j.zefq.2015.06.001. Epub 2015 Jul 16. Review. German.

PMID:
26699261
17.

Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

Scully CG, Forrest S, Galeotti L, Schwartz SB, Strauss DG.

Ann Emerg Med. 2015 Apr;65(4):400-3. doi: 10.1016/j.annemergmed.2014.07.008. Epub 2014 Aug 13. Review.

PMID:
25128009
18.

A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe.

Campillo-Artero C.

Health Policy. 2013 Nov;113(1-2):38-44. doi: 10.1016/j.healthpol.2013.03.017. Epub 2013 Apr 17. Review.

PMID:
23602548
19.

How many testers are needed to assure the usability of medical devices?

Borsci S, Macredie RD, Martin JL, Young T.

Expert Rev Med Devices. 2014 Sep;11(5):513-25. doi: 10.1586/17434440.2014.940312. Epub 2014 Jul 18. Review.

PMID:
25033757
20.

[Overview on the market, supervision and standardization of nanomaterial-contained medical devices].

Shao A, Xu L.

Zhongguo Yi Liao Qi Xie Za Zhi. 2015 Jan;39(1):51-5. Review. Chinese.

PMID:
26027296

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